Apical Periodontitis, Root Canal Infection
Conditions
Keywords
apical periodontitis, copious irrigation, mechanical root canal preparation
Brief summary
The aim of the study is first, to evaluate the clinical antibacterial efficacy of two different NaOCl concentrations (2,5% and 5%) under a predefined irrigant flow rate in teeth with pulp necrosis and apical periodontitis by using Real-time PCR. . Second, to evaluate the efficacy of final irrigation by assessing, if possible, a numerical definition for that so called as copious irrigation. Besides the total microbial load, the antibacterial efficacy of final irrigation procedure against two different bacterial species (namely Pseudoramibacter alactolyticus and Treponema denticola) will also be examined.
Detailed description
The antibacterial efficacy of two different NaOCl concentrations (2,5% and 5%) under a predefined irrigant flow rate in teeth with pulp necrosis and apical periodontitis will be examined through the calculation of the total bacterial load before any treatment procedure and the possible bacteria reduction after each treatment procedure (chemomechanical preparation, and final irrigation treatments). In addition, the antimicrobial efficacy of the above two different concentrations of NaOCl will be compared in terms of treatment outcome. All patients will be asked for one-year recall examination where the outcome of endodontic treatment will be evaluated through clinical and radiographic examination. For the identification of thecopious irrigation the total amount of final irrigation will be divided in two equal parts of volume/ time (15ml for 5 minutes each). Total bacterial load that will remain after chemomechanical preparation will be compared to the number of bacteria calculated after the first and the second part of irrigation. It will be investigated if final irrigation provides to further microbial reduction and whether prolonged irrigation augments the antibacterial effect. Besides the total microbial load, the antibacterial efficacy of final irrigation procedure against two different bacterial species (namely Pseudoramibacter alactolyticus and Treponema denticola) will also be examined. First, the prevalence of these specific species will be investigated in primary endodontic infections in Greek-living population. In addition, the effect of chemomechanical preparation and final irrigation procedure on the number of these species will be relatively examined though the reduction curves that will be obtained by qPCR.
Interventions
PROCEDURERoot canal tratment using mecchanical and chemical preparation.
Root canal procedures including access cavity preparation, chemomechanical instrumentation, irrigation with sodium hypoclorite (NaOCl), microbiological sampling and obturation with warm vertical compaction.
DRUGSodium Hypochlorite.
Sodium Hypoclorite used as the primary irrigant in the root canal treatment at concentrations of 2.5% (Group A) and 5% (Group B).
DRUGHydrogen peroxide.
Applied to the operating field and tooth as part of initial disinfection prior to cavity access.
DRUGSodium Sulfate.
Used to inactivate sodium hypoclorite prior to sample collection.
DEVICERoot ZX mini apex locator (Morita).
Used to determine the working length of the root canal.
DEVICEProtaper Gold rotary files (Dentslpy Maillefer).
Used for coronal flaring in root canal instrumentation.
DEVICESmarttrack and Hyflex totary files.
Used for root canal instrumentation to full working length.
DEVICEEndo-Eze 27G irrigation needle (Ultradent).
Used to deliver irrigant into the root canal.
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The present research will be designed as two-arm, parallel, randomized clinical study. The randomization of the teeth for sampling will be performed through the use of a special software . All the treatment and sampling procedures will be carried out by the same investigator (PhD candidate Dr. Agapi Zervaki).
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Informed consent by the patients who wish to participate in the study. * Single-rooted teeth with pulp necrosis confirmed by pulp sensibility tests, negative response to both cold and electric pulp testing and radiographic evidence of apical periodontitis. * Teeth with relatively straight canals, complete root development and no pulp canal obliteration.
Exclusion criteria
* Patients who have received antibiotic treatment the last 3 months or need chemoprophylaxis for dental treatment. * Teeth with previous endodontic treatment. * Teeth with cracks or incomplete vertical root fracture which disturbs the integrity of the pulp chamber walls. * Teeth with periodontal pocket more than 4mm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of total bacterial load after chemomechanical preparation using 2.5% and 5% NaOCl. | DAY 1: Immediately after chemomechanical preparation. | Clinical antibacterial efficiency of two different NaOCl concentrations (2.5% and 5%) will be assessed by measuring the total bacteria load reduction using qPCR. The unit measure is the Log reduction in total Bacterial DNA copies per sample. |
| Clinical and radiographic treatment success. | 1 year post tratment. | Comparison of endodontic treatment outcome between the two NaOCl concentrations groups, assessed by clinical exam and periapical index (PAI). Unit measure: Number of teeth scored as healed PAI \<2 vs not healed PAI\>3. Scale Information: The Periapical Index (PAI) is a radiographic scoring system ranging from 1 to 5, where: 1 = Normal periapical structures (best outcome) 5 = Severe periodontitis with exacerbating features (worst outcome) Lower scores indicate better healing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional bacterial load reduction between two sequential 15 ml irrigation periods | Beteen 1 and 6 months after samples collection. | Evaluation of copious irrigation effectiveness by measuring bacterial load after each of two equal 15 ml/5 min final irrigation stages. Unit of Measure: Log reduction in total bacterial DNA copies per sample |
| Prevalence of Pseudoramibacter alactolyticus and Treponema denticola in primary infections | Beteen 1 and 6 months after samples collection.) | Detection and prevalence rate of two specific bacterial species in untreated teeth with apical periodontitis using qPCR. Unit of Measure: Presence/absence and DNA copy number |
| Reduction in P. alactolyticus and T. denticola load after treatment procedures | Beteen 1 and 6 months after samples collection. | Quantification of bacterial load changes in P. alactolyticus and T. denticola following chemomechanical preparation and final irrigation. Unit of measure: Log reduction in species-specific DNA copy numbers |
Countries
Greece
Outcome results
None listed